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Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee

NCT02121002 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1176

Last updated 2021-06-16

Study results available
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Summary

To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.

Conditions

Interventions

DRUG

Diclofenac Sodium Topical Gel, 1%

Opaque, white gel

DRUG

Voltaren Topical Gel, 1%

Opaque, white gel

DRUG

Vehicle Diclofenac Sodium Topical Gel

Opaque, white gel

Sponsors & Collaborators

  • Sristek Clinical Research Solutions Limited

    collaborator INDUSTRY

  • Amneal Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Prayag Shah, MD · Amneal Pharmaceuticals, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02121002 on ClinicalTrials.gov